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GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Recalled July 16, 2025 · FDA recall Z-2097-2025 · GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Hazard
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury. · FDA Class II
Units
1822
Sold at
Worldwide - US Nationwide distribution.
Description
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
Product
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Manufacturer(s)
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Made in
Israel
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →